Latest news with #ZaiLabLimited
Business Wire
10-07-2025
- Business
- Business Wire
Zai Lab to Announce Second Quarter 2025 Financial Results and Recent Corporate Updates on August 7, 2025
SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report its second quarter 2025 financial results and provide recent corporate updates on August 7, 2025, before the opening of U.S. equity markets. The announcement will be followed by a conference call and webcast at 8:00 a.m. ET (8:00 p.m. HKT). Conference Call and Webcast Information Listeners may access the live webcast by visiting the Company's website at Participants must register in advance of the conference call. Details are as follows: Registration link for webcast (preferred): Registration link for dial-in: All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering. A replay will be available shortly after the call and can be accessed by visiting the Company's website. About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide. For additional information about Zai Lab, please visit or follow us at
Business Wire
30-06-2025
- Business
- Business Wire
Zai Lab Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-Line Gastric Cancer
SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis. Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive. FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry (IHC) testing. Gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and over 650,000 deaths globally each year 1, highlighting a critical unmet medical need. In China, there are over 350,000 new cases each year. The disease is associated with a poor prognosis, particularly in advanced stages where the five-year survival rate is less than 10%. There are currently no approved therapies specifically targeting FGFR2b overexpression in gastric cancer in China. 'Bemarituzumab is the first FGFR2b inhibitor to demonstrate a statistically and clinically significant overall survival benefit in a randomized Phase 3 trial for the first-line treatment of FGFR2b-positive gastric cancer,' said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. 'The success of the global Phase 3 FORTITUDE-101 study highlights the potential of bemarituzumab to redefine the standard of care for a patient population that has faced poor outcomes with existing therapies. We are proud to have contributed meaningfully to this pivotal trial, including a substantial number of patients enrolled in China. Based on these results, and the regulatory Breakthrough Designation, we plan to move rapidly toward regulatory submission in China to bring this transformative therapy to patients as quickly as possible.' The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anaemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm. Detailed results from the trial will be shared at a future medical meeting. Zai Lab holds the development and commercialization rights for bemarituzumab for mainland China, Hong Kong, Macau, and Taiwan. Bemarituzumab has been granted Breakthrough Therapy designation by the China Center for Drug Evaluation of the National Medical Products Administration for the treatment of FGFR2b-positive gastric and gastroesophageal junction adenocarcinoma. A Phase 3 study of bemarituzumab plus chemotherapy and nivolumab is also ongoing in patients with first-line gastric cancer, with data readout anticipated in H2 2025. About FGFR2b The FGFR2b protein (also known as fibroblast growth factor receptor 2b) is an emerging biomarker which, when overexpressed, promotes aberrant signaling leading to tumor cell proliferation. 2 The FGFR2b protein is overexpressed by G/GEJ tumor cells in approximately 38% of patients with advanced G/GEJ cancer. FGFR2b protein overexpression is defined as 2+/3+ staining intensity on tumor cell membrane, as detected by immunohistochemistry (IHC) testing. In approximately 16% of patients with advanced G/GEJ cancer, FGFR2b protein overexpression is observed on ≥10% of tumor cells by IHC. 3 About FORTITUDE-101 FORTITUDE-101 is a randomized, multi-center, double-blind, placebo-controlled Phase 3 study of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 as first-line therapy in advanced G/GEJ cancer with FGFR2b overexpression. The FORTITUDE-101 trial spanned 300 sites across 37 countries, with 547 patients enrolled. The primary outcome measure of the trial is overall survival in patients with FGFR2b ≥10% 2+/3+ tumor cell staining. Key secondary outcome measures include progression-free survival and overall response rate. Candidates were excluded from the trial if they were known to be human epidermal growth factor receptor 2 (HER2) positive. FORTITUDE-101 included more comprehensive ocular-related monitoring than previous studies of bemarituzumab. About Gastric Cancer in China Gastric cancer is the fifth most common cancer worldwide, while China bears one of the highest gastric cancer burdens in the world with an estimated 358,700 new cases and 260,400 deaths annually. 4 In China, approximately 80% of gastric cancer patients are diagnosed at an advanced or metastatic stage 5. For those diagnosed with Stage IV gastric cancer, the overall 5-year survival rate is less than 10% 6. Patients with advanced gastric and GEJ cancer that overexpress the FGFR2b protein may be associated with poor prognosis 7-10. About Zai Lab Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit or follow us at Zai Lab Forward Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements regarding the prospects and plans for developing and commercializing bemarituzumab, the potential benefits of bemarituzumab, and the potential treatment of gastric and gastroesophageal junction cancer. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'plan,' 'possible,' 'potential,' 'will,' 'would,' and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC's website at REFERENCES Bray F, et al. CA Cancer J Clin. 2024;74(3);229-263 Wainberg ZA, et al. Lancet Oncol. 2022;23(11):1430-40 Rha SY, et al. JCO Precis Oncol. 2025; 9 (e2400710). DOI:10.1200/PO-24-00710 Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. Health Commission of The People's Republic Of China N. National guidelines for diagnosis and treatment of gastric cancer 2022 in China (English version). Chin J Cancer Res. 2022;34(3):207-237. Li HQ, Zhang H, Zhang HJ, Wang YX, Wang XB, Hou HF. Survival of gastric cancer in China from 2000 to 2022: A nationwide systematic review of hospital-based studies. J Glob Health 2022;12:11014. Catenacci D, et al. Presented at American Society of Clinical Oncology; June 4-8, 2021; Online Virtual Scientific Program. Abstract 4010. Ahn S, et al. Mod Pathol. 2016;29:1095-1103. Ishiwata T. Front Biosci (Landmark Ed). 2018;23:626-639. Wainberg ZA, et al. Lancet Oncol. 2022;23:1430-1440.
Yahoo
13-06-2025
- Business
- Yahoo
Zai Lab Presents New Preclinical Data for ZL-1503, an IL-13/IL-31R Bispecific Antibody for the Treatment of Atopic Dermatitis, at EAACI Congress 2025
-Data highlights potential of ZL-1503 as a promising treatment for moderate-to-severe atopic dermatitis and other IL-13 and IL-31-driven diseases -Favorable preclinical safety profile, prolonged half-life and durable suppression of both inflammatory and pruritogenic pathways support advancement of ZL-1503 to IND-enabling studies -Zai Lab plans to file an IND for ZL-1503 for moderate-to-severe atopic dermatitis by the end of 2025 SHANGHAI & CAMBRIDGE, Mass., June 13, 2025--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced new data from its preclinical study of ZL-1503, the Company's promising IL-13/IL-31R bispecific antibody, demonstrating its ability to simultaneously suppress the inflammatory and pruritogenic (itch-causing) pathways in atopic dermatitis (AD). The findings, featured during a poster presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 in Glasgow, Scotland, highlight the potential of ZL-1503 as a novel treatment option for moderate-to-severe AD. Medications that inhibit IL-4/IL-13 signaling have markedly improved the therapeutic landscape for AD. Certain AD symptoms are mediated by IL-31; however, they are only partially alleviated by IL-4/IL-13 inhibition. As a result, many patients experience slow and modest clinical responses to currently available medications. ZL-1503 was evaluated in a pilot preclinical study in non-human primates to assess its long-term effects on IL-31-mediated scratching and IL-13-induced signaling (pSTAT6). Key study results presented at the EAACI Congress 2025 include: An intravenous single dose of ZL-1503 (10 mg/kg, iv) completely inhibited IL-13-mediated pSTAT6 and IL-31-induced scratching for at least 76 days in all preclinical subjects. Two out of three subjects exhibited prolonged IL-13-mediated pSTAT6 inhibition for over 118 days, and one out of three subjects sustained IL-31-induced scratching inhibition for over 133 days. Pharmacokinetic (PK) analysis of serum samples collected during the study revealed that ZL-1503 exhibited slow clearance, correlating closely pharmacodynamic (PD) responses, demonstrating strong PK/PD relationships in blocking IL-13 and IL-31 pathways in the preclinical model. ZL-1503 was well tolerated following weekly IV dosing up to 150 mg/kg. Additionally, in vitro studies showed that binding to one target did not affect ZL-1503's blocking effects on the other target. Details regarding the ZL-1503 poster presentation at EAACI Congress 2025 are as follows: Title: ZL-1503: A Bispecific Antibody Targeting Inflammatory and Pruritogenic Pathways with a Prolonged Serum Half-life and Sustained Activity in Non-human Primates Presenter: Linda Liu, Ph.D., Senior Vice President, Biologics Discovery, Zai LabSession Title: Thematic Poster Session 18 (TPS18), Biologicals 01Date/Time: Friday, June 13, 2025, from 12:00 - 13:00 BSTAbstract Number and Location: n°000625 & Poster Prefix D1.365, Poster Zone About Zai Lab Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit or follow us at Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements regarding product candidates in our pipeline including ZL-1503 and related preclinical studies; the potential benefits of ZL-1503; and the potential treatment of atopic dermatitis and other diseases involving the IL-13 and IL-31 pathways. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would," and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC's website at View source version on Contacts Investor Relations: Christine Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257 / Media: Shaun Maccoun / Xiaoyu Chen+1 (857) 270-8854 / +86 185 0015 / Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
13-06-2025
- Health
- Business Wire
Zai Lab Presents New Preclinical Data for ZL-1503, an IL-13/IL-31R Bispecific Antibody for the Treatment of Atopic Dermatitis, at EAACI Congress 2025
SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced new data from its preclinical study of ZL-1503, the Company's promising IL-13/IL-31R bispecific antibody, demonstrating its ability to simultaneously suppress the inflammatory and pruritogenic (itch-causing) pathways in atopic dermatitis (AD). The findings, featured during a poster presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 in Glasgow, Scotland, highlight the potential of ZL-1503 as a novel treatment option for moderate-to-severe AD. Medications that inhibit IL-4/IL-13 signaling have markedly improved the therapeutic landscape for AD. Certain AD symptoms are mediated by IL-31; however, they are only partially alleviated by IL-4/IL-13 inhibition. As a result, many patients experience slow and modest clinical responses to currently available medications. ZL-1503 was evaluated in a pilot preclinical study in non-human primates to assess its long-term effects on IL-31-mediated scratching and IL-13-induced signaling (pSTAT6). Key study results presented at the EAACI Congress 2025 include: An intravenous single dose of ZL-1503 (10 mg/kg, iv) completely inhibited IL-13-mediated pSTAT6 and IL-31-induced scratching for at least 76 days in all preclinical subjects. Two out of three subjects exhibited prolonged IL-13-mediated pSTAT6 inhibition for over 118 days, and one out of three subjects sustained IL-31-induced scratching inhibition for over 133 days. Pharmacokinetic (PK) analysis of serum samples collected during the study revealed that ZL-1503 exhibited slow clearance, correlating closely pharmacodynamic (PD) responses, demonstrating strong PK/PD relationships in blocking IL-13 and IL-31 pathways in the preclinical model. ZL-1503 was well tolerated following weekly IV dosing up to 150 mg/kg. Additionally, in vitro studies showed that binding to one target did not affect ZL-1503's blocking effects on the other target. Details regarding the ZL-1503 poster presentation at EAACI Congress 2025 are as follows: Title: ZL-1503: A Bispecific Antibody Targeting Inflammatory and Pruritogenic Pathways with a Prolonged Serum Half-life and Sustained Activity in Non-human Primates Presenter: Linda Liu, Ph.D., Senior Vice President, Biologics Discovery, Zai Lab Session Title: Thematic Poster Session 18 (TPS18), Biologicals 01 Date/Time: Friday, June 13, 2025, from 12:00 - 13:00 BST Abstract Number and Location: n°000625 & Poster Prefix D1.365, Poster Zone About Zai Lab Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit or follow us at Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements regarding product candidates in our pipeline including ZL-1503 and related preclinical studies; the potential benefits of ZL-1503; and the potential treatment of atopic dermatitis and other diseases involving the IL-13 and IL-31 pathways. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'plan,' 'possible,' 'potential,' 'will,' 'would,' and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC's website at
Yahoo
02-06-2025
- Business
- Yahoo
NovoCure's Tumor Treating Fields Boost One-Year And Pain-Free Survival In Pancreatic Cancer Trial
Zai Lab Limited (NASDAQ:ZLAB) and NovoCure Limited (NASDAQ:NVCR) revealed additional data on Saturday from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for pancreatic cancer. The data were presented at the 2025 American Society of Clinical Oncology Annual Meeting. The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) for patients treated with TTFields. In the intent-to-treat population, patients treated with TTFields therapy concomitantly with gemcitabine and nab-paclitaxel had an mOS of 16.2 months compared to 14.2 months for patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement. TTFields therapy concomitant with gemcitabine and nab-paclitaxel demonstrated improvement in several secondary endpoints, including one-year and pain-free survival rates. The one-year survival rate showed a statistically significant improvement in the TTFields concomitant with gemcitabine and nab-paclitaxel treated group, 68.1%, compared to 60.2% for those who received gemcitabine and nab-paclitaxel alone. Patients treated with TTFields concomitant with gemcitabine and nab-paclitaxel had a median pain-free survival of 15.2 months compared to a median of 9.1 months in the group treated with gemcitabine and nab-paclitaxel alone. This is a statistically significant 6.1-month extension in pain-free survival. Pain-free survival was defined as the time from baseline until patients reported an increase of 20 or more points on a visual scale for pain or until death. There was no statistically significant difference in additional secondary outcome measures of progression-free survival, local progression-free survival, objective response rate, puncture-free survival, or tumor resectability rate between the TTFields with gemcitabine and nab-paclitaxel and the gemcitabine and nab-paclitaxel arms. TTFields therapy was well-tolerated, no new safety signals were observed, and safety was consistent with prior clinical studies. Mild to moderate skin adverse events (AEs) were the most common device-related AEs. Price Action: NVCR stock is trading lower by 8.63% to $17.46 at last check Monday. Read Next:Photo by Aunt Spray via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article NovoCure's Tumor Treating Fields Boost One-Year And Pain-Free Survival In Pancreatic Cancer Trial originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
